Job Summary

• The Regulatory Affairs Specialist is responsible for ensuring quality systems aspects such as CAPA management, global procedure review and participation in cross-site Global Regulatory Affairs initiatives in addition to product registration, IVDR document maintenance and minor/moderate design change management for the AU Chemistry Product line.
• You will be a part of the Regulatory Affairs team and report to the Regulatory Affairs Manager, be responsible for providing regulatory support to local regulatory team on site, Beckman Coulter customers and Beckman Coulter’s commercial regulatory teams globally.
• This is a contract role for 18 months where you will have the opportunity to act as RA representative on Design Change projects which includes the development and implementation of registration strategies.

Matching Summary

Skills & Requirements

Key Requirements

• B.Sc. Level in a Science related field
• minimum of 3 years’ experience
• QA or RA role within a manufacturing facility
• Excellent written and communication skills

Work Rights